KEY TAKEAWAYS
- CALLA Phase III (NCT03830866) was a randomized, global study on treatment options for women with LACC.
- The study aimed to evaluate Durvalumab as a combination treatment and the standard of care concurrent chemoradiation therapy(SoC CCRT) after following it with a Durvalumab monotherapy.
- The primary outcome measure for this study was Progression-free Survival which did not improve significantly compared to SoC CCRT.
- Clinically significant results advocating Durvalumab were not reached.
The first global Phase 3 trial, known as CALLA, compares immune checkpoint inhibition (Durvalumab) to placebo when combined with and after platinum-based chemoradiotherapy (CRT) in locally advanced cervical cancer (LACC).
FIGO 2009 stages IB2-IIB node-positive, IIIA-IVA with any node status, newly diagnosed, untreated individuals with LACC were randomized 1:1 to Durvalumab (1500 mg IV) or placebo Q4W, for up to 24 months, in conjunction with and after CRT. CRT included weekly concomitant IV cisplatin treatment along with EBRT and brachytherapy. RT quality was tracked, and any changes were assessed for clinical relevance. PFS is the main outcome, with OS, objective response rate, local/distant cancer progression incidence, and safety as secondary outcomes.
At 120 locations across 15 countries, 770 patients were randomly assigned (N=385 per arm). The median follow-up was 18.5 months, and the median age was 49 years.
PFS did not statistically differ significantly between durvalumab+CRT and placebo+CRT (HR 0.84 [95% CI, 0.65-1.08]; P=0.174); on the same line, the OS did not differ significantly, though the data were preliminary and not officially tested. In the durvalumab+CRT and placebo+CRT arms, respectively, 51.7% and 51.0% of patients experienced adverse events (AEs) of grade 3–4; 12.5% and 9.6% of patients discontinued treatment due to AEs potentially linked to the study drug.
Durvalumab did not substantially prolong PFS in patients with LACC when used with and after CRT. However, no new or unexpected toxicity was observed, and the overall safety of durvalumab+CRT was similar to that of CRT alone.
Source: https://cslide.ctimeetingtech.com/igcs22/attendee/confcal/show/session/4
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03830866
Monk, B. J. (2022). DURVALUMAB, IN COMBINATION WITH AND FOLLOWING CHEMORADIOTHERAPY, IN LOCALLY ADVANCED CERVICAL CANCER: RESULTS FROM THE PHASE 3 INTERNATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CALLA TRIAL. 2022 IGCS Meeting Program Scheduling. https://cslide.ctimeetingtech.com/igcs22/attendee/confcal/show/session/4
